SAPIEN M3 System for Mitral Regurgitation

(SAPIEN M3 EFS Trial)

Recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Must be taking: Heart failure medication

Disqualifiers: Severe pulmonary hypertension, Renal insufficiency, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Procedure day

74 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test the safety and effectiveness of the SAPIEN M3 System in patients with severe mitral regurgitation. The device is designed to help the heart valve close properly, preventing blood from flowing backward. The study aims to gather information for future research on this treatment. The SAPIEN M3 System is part of the SAPIEN family of heart valves, which have been used in various applications including aortic and mitral valve replacements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be stable on heart failure medication for at least 2 weeks before the procedure.

What data supports the effectiveness of the SAPIEN M3 System treatment for Mitral Regurgitation?

The Edwards Sapien 3 valve, a component of the SAPIEN M3 System, has been optimized to reduce complications in aortic valve treatments, suggesting potential effectiveness in similar heart valve conditions. Additionally, the PASCAL system, another Edwards Lifesciences device for mitral regurgitation, has shown positive outcomes in reducing mitral valve issues, indicating that similar technologies from the same company may be effective. ^{1 2 3 4 5}

Is the SAPIEN M3 System generally safe for humans?

The Edwards SAPIEN transcatheter heart valve, a related device, has been evaluated for safety in high-risk patients with aortic stenosis and was found to have benefits that outweigh the risks, according to an FDA panel. Additionally, early trials for similar devices in different heart conditions have been conducted to assess safety. ^{1 6 7 8 9}

How is the SAPIEN M3 System treatment for mitral regurgitation different from other treatments?

The SAPIEN M3 System is unique because it uses a transcatheter approach, meaning it is delivered through a small tube inserted into a blood vessel, which is less invasive than traditional surgery. This system is adapted from the SAPIEN 3 valve, which is known for its precise implantation and reduced risk of leakage around the valve, making it a novel option for treating mitral regurgitation. ^{1 2 3 10 11}

Eligibility Criteria

This trial is for adults with severe mitral valve regurgitation who are at high risk for heart surgery, stable on heart failure meds, and not pregnant. They must understand the study and consent to it. Excluded are those with other valve issues, mechanical aortic valves, history of certain cardiovascular events or procedures within specified time frames, participation in another study, refusal of blood products, specific cardiac conditions that could interfere with treatment effectiveness or safety.

Inclusion Criteria

I am 18 years old or older.

You have heart problems that affect your ability to do physical activities.

The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

Your heart's shape would make it difficult to put in the device or valve correctly.

I have kidney problems or am on dialysis.

I have liver disease or abnormal liver test results.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects will undergo transcatheter mitral valve replacement using the SAPIEN M3 System

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including reduction in mitral regurgitation

30 days

1 visit (in-person)

Treatment Details

Interventions

• Edwards SAPIEN M3 System

Trial Overview The Edwards SAPIEN M3 System is being tested to see if it's safe and works well for treating severe symptomatic mitral regurgitation (MR). The trial will help design future studies by collecting initial data on this new medical device's performance.

Participant Groups

Group I: TMVR Experimental Treatment 1 Intervention

Subjects will undergo transcatheter mitral valve replacement

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Findings from Research

In a study of 235 patients with severe aortic stenosis, the use of the Edwards Sapien 3 valve for transcatheter aortic valve implantation (TAVI) resulted in no cases of moderate or severe residual aortic regurgitation, indicating high device success.

The procedure, performed without general anesthesia, showed low rates of major vascular complications (3.0%), mortality (2.6%), and stroke (2.1%) within 30 days, demonstrating its safety and efficacy across different valve sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience. Wöhrle, J., Gonska, B., Rodewald, C., et al.[2019]

The PASCAL system effectively treated severe mitral regurgitation (MR) in 92 patients, achieving a high overall success rate of 97.8%, with significant improvements in MR severity and patient quality of life at follow-up.

Patients experienced notable reductions in proBNP levels and pulmonary capillary wedge pressure, indicating improved heart function, with a low major adverse event rate of only 1.2% cardiovascular death at 30 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and hemodynamic results after transcatheter mitral valve leaflet repair with the PASCAL device depending on etiology in a real-world cohort. Barth, S., Shalla, A., Kikec, J., et al.[2022]

The Edwards SAPIEN transcatheter heart valve (THV) is considered noninferior to traditional surgical aortic valve replacement for high-risk operable patients, based on the high-risk arm of the PARTNER trial.

Despite some concerns about safety and trial misconduct, the FDA panel unanimously agreed that the benefits of the Edwards SAPIEN THV outweigh the risks, leading to its approval for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients. Barbash, IM., Dvir, D., Waksman, R.[2013]

The LOTUS valve system and the Edwards SAPIEN 3 prosthesis showed comparable early safety outcomes in treating aortic stenosis, with similar rates of complications (14.3% for LOTUS vs. 14.6% for Edwards SAPIEN 3).

However, patients receiving the LOTUS valve had a significantly higher rate of requiring a permanent pacemaker (34.3% for LOTUS vs. 14.1% for Edwards SAPIEN 3), indicating a potential drawback in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repositionable Versus Balloon-Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis. Pilgrim, T., Stortecky, S., Nietlispach, F., et al.[2018]

The Edwards SAPIEN transcatheter heart valve demonstrated a high success rate of 97.1% in deployment among 36 patients with moderate to severe pulmonary regurgitation, indicating its effectiveness in this patient population.

At 6-month follow-up, 97% of patients experienced significant improvements in their condition, with most showing reduced pulmonary regurgitation and a notable increase in functional status, suggesting the procedure is both safe and beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: early phase 1 results from an international multicenter clinical trial. Kenny, D., Hijazi, ZM., Kar, S., et al.[2022]

The SAPIEN XT transcatheter heart valve system is associated with significantly fewer overall and major vascular complications compared to the original SAPIEN system, making it a safer option for patients with severe aortic stenosis who cannot undergo surgery.

Both SAPIEN and SAPIEN XT systems showed similar effectiveness in reducing all-cause mortality, major stroke, and rehospitalization rates at one year, indicating that the newer SAPIEN XT system maintains therapeutic efficacy while improving safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Evaluation of the SAPIEN XT Transcatheter Heart Valve System in Patients With Aortic Stenosis Who Are Not Candidates for Surgery. Webb, JG., Doshi, D., Mack, MJ., et al.[2022]

The SAPIEN 3 transcatheter valve demonstrated high safety and efficacy, with 96.4% of patients experiencing none to mild paravalvular regurgitation and a low mortality rate of 2.1% when using the transfemoral approach.

This third-generation valve shows promise as a viable alternative to high- or intermediate-risk surgical options for severe aortic stenosis, particularly due to its improved ease of use and accuracy in positioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. Webb, J., Gerosa, G., Lefèvre, T., et al.[2022]

The surgical implantation of the Edwards Sapien 3 valve in a severely ill child with prosthetic valve endocarditis was performed safely, demonstrating effective short-term hemodynamic results.

This case suggests that the Sapien 3 valve is a promising option for treating mitral valve disease in children, particularly when a bioprosthesis is needed during valve re-replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Edwards Sapien 3 Valve for Mitral Replacement in a Child After Melody Valve Endocarditis. Trezzi, M., Cetrano, E., Iacobelli, R., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Functional and hemodynamic results after transcatheter mitral valve leaflet repair with the PASCAL device depending on etiology in a real-world cohort. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device. [2021]

5. England pubmed.ncbi.nlm.nih.gov

One-Year Outcomes According to Mitral Regurgitation Etiology Following Transcatheter Edge-to-Edge Repair With the PASCAL System: Results From a Multicenter Registry. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Repositionable Versus Balloon-Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: early phase 1 results from an international multicenter clinical trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Randomized Evaluation of the SAPIEN XT Transcatheter Heart Valve System in Patients With Aortic Stenosis Who Are Not Candidates for Surgery. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Edwards Sapien 3 Valve for Mitral Replacement in a Child After Melody Valve Endocarditis. [2017]